UNIVERSITY OF LIMERICK RESEARCH ETHICS COMMITTEE

For Office Use Only: EHSREC No: EHSREC11-36 RA01 _ UNIVERSITY OF LIMERICK RESEARCH ETHICS COMMITTEE Risk Assessment Form Procedures Involving Human Subjects Procedure No EHSREC11-36 RA01 Title of Procedure Residential simulated altitude acclimation (normobaric hypoxia) Name of Assessor(s) Prof P. Jakeman and Dr. R. McMorris Assessment Date 25/06/2011 Does this procedure already have ethical approval? (Delete as appropriate) YES/NO If YES, enter ethical number and expiry date Approval No: EHSREC11-36 RA01 Expiry Date: 31/12/2014 1 Please provide a brief description of the procedure Summary: People regularly travel to altitude for short (days) or long (weeks to months) as part of their occupation or for recreational purposes (mountain climbing, trekking, skiing). Similarly, athletes travel to altitude to gain an enhancement in performance. Altitude acclimation is a widely adopted practice in sport. In low-lying countries like Ireland, athletes travel to countries with mountainous regions to undertake altitude acclimation. Alternatively, an altitude environment can be simulated at sea-level by controlling the amount of oxygen present in room air. This simulated altitude is known as normobaric hypoxia 1. The National Altitude Training Centre is a residential facility within which the altitude can be simulated to generate normobaric hypoxia that is controlled at a specified programme of altitude acclimation. This risk assessment addresses the most widely applied paradigm for athletes engaging in Altitude Training i. Residential Simulated Altitude Acclimation whereby the subject resides within the simulated attitude environment, normally for a period of 12-16h per day (e.g. 6pm to 8 am) but, ii. undertakes his/her training session(s) in normal ambient air (e.g. at the Arena). This simulates the live high-train-low paradigm is normally undertaken for a period ranging from 14 to 28d. 1 Note: The Medical Commission of the Union Internationale des Associations d Alpinisme (UIAA) is the world umbrella organization for health and safety at altitude. UIAA MedCom provides guidelines to the risks and precautions associated with Limited Exposure (for some days or weeks) to normobaric hypoxia. These guidelines form the basis of the Risk Assessment and Operating Procedures governing simulated altitude exposure conducted within the National Altitude Training Centre @ UL. November 2011 Page 1

Components of the Risk Assessment: 1. Operation of the National Altitude Training Centre The operational construct of the National Altitude Training Centre (NATC) @ UL is provided in Appendix I. This statement includes the general design, floor plan, hypoxic control and safety aspects pertaining to the building and equipment and the management of the facility. 2. Risks and Precautions of Limited Exposure to Altitude An appraisal of the guidelines for healthy subjects undertaking limited exposure (days to weeks) to simulated altitude generated by normobaric hypoxia is provided in Appendix II. This statement includes the risks and precautions associated with limited altitude exposure and procedures for the screening and management of subjects in an altitude environment. 2 Location in which the procedure may take place National Altitude Training Centre, 56, Kilmurry Village, University of Limerick 3 Eligibility of subject(s) to be used UL students (U.G. or P.G.) engaged in simulated altitude projects granted ethical approval. University staff or campus personnel engaged in simulated altitude projects granted ethical approval. Members of the general public engaged in simulated altitude projects granted ethical approval. 4 Potential risks. To be explained before obtaining consent None, or minimal discomfort only If the risks are other than trivial please provide a brief description. The principal risk to the subject is an acute reaction to hypoxia known as Acute Mountain Sickness (AMS). This is dealt with in detail in the attached procedures. 5 Action to be taken in the event of an foreseeable emergency Please provide a clear statement of appropriate action including contact names and telephone numbers. 1. Stop the procedure. Remove the subject from the hypoxic environment or open the windows to allow normal air into the room. Position the subject to prevent self-injury. 2. Raise the subject s lower limbs to improve blood flow and counteract the vasovagal influence. Should the subject fail to respond summon help, immediately. 3. Check vital signs airways, breathing and circulation (ABC) 4. If required, attempt CPR 5. If required, use AED 6. Contact telephone numbers: a. During normal working hours 9am-5pm, use NATC phone to contact the Student Health Centre on 2534 b. Outside of normal working hours, or if the Student Health Centre number is engaged/busy, use the NATC phone to dial 3333 for UL security personnel who will then contact the ambulance service. When contacting the above clearly state: November 2011 Page 2

Location : National Altitude Training Centre, House 56, Kilmurry Village. Incident: Subject in difficulty from exposure to simulated altitude. 6 Level of supervision required for procedure Persons trained in the acute effects of hypoxia 7 Other documentation required for this assessment? PRESAT subject questionnaire AMS questionnaire (SARRS) For Office Use Only: EHSREC11-36 RA01 November 2011 Page 3

FOR COMPLETION BY HEAD OF DEPARTMENT Risk Assessment Form Procedures Involving Human Subjects In the Department of : Physical Education and Sport Sciences Procedure No EHSREC11-36 RA01 Title of Procedure Residential simulated altitude acclimation (normobaric hypoxia) Name of Assessor(s) Prof P. Jakeman and Dr. R. McMorris Assessment Date 26/06/2011 8 Approval of procedure Granted Subject to conditions (see below) Others, please specify Comments/conditions Signed: (Head of Department) Date: November 2011 Page 4

Specifications of the Residential Simulated Altitude House. The University of Limerick has converted 56, Kilmurry Village into a residential simulated altitude house. The house comprises 7 bedrooms (dimensions 242cm (h) x 254cm (w) x 301cm (d) = 33.43m 3 : total space = 267.44m 3 ) complete with a Living Space (dimensions 246cm (h) x 437cm (w) x 307cm (d) = 33.00m 3 + 246cm (h) x 335cm (w) x 485cm (d) = 39.97m3: total space = 72.97m 3 ). Hypoxic Control: The hypoxic (lower than sea level ambient oxygen concentration, i.e. 20.9% O 2 ) control system is located within a secure room of the altitude house. The control panel is also monitored from a remote site from the Altitude Centre. The Hypoxico system governing the air conditioning within this environment is capable of maintaining a conditioned environment ranging from normal ambient air @ 20.93% O 2 through to a low of 11% O 2 within the bedrooms and the living area. This provides an effective altitude range from sea level to approximately 5000m. The control system maintains the oxygen level in the space within a resolution of 0.1%. The altitude meter equivalent display is calibrated to the nearest 0.1% changes in O 2. The system is password protected: password is available to authorised personnel only. Residents using the altitude house will NOT be able to alter the altitude environment. Override and Safety Lock Out. All the equipment is CE certificated. All rooms are fitted with oxygen monitors. The oxygen sensors produce an independent audible alarm within the room if the pre-programmed alarm threshold is reached. The oxygen monitors are password protected to avoid tampering. In the event of an error signal from the O 2 sensor the system will shut down. The safety override system will deliver 20.9% O2 (ambient air) to the room. If the system failure the air environment returns to its non-conditioned state, i.e. normoxic 20.9% O 2 Project Management and Standard Operation Procedure: Joe O Brien of Kelly, Barry, O Brien & Whelan was appointed Project Manager in conjunction with Buildings and Estates @ UL. Richard Pullen from The Altitude Centre Ltd, London was the consultant appointed to supply and fit the air conditioning and control system. A Standard Operating Procedure (SOP) has been approved and formally adopted into University s Health and Safety Policy and Professional Indemnity Cover agreed by the University s insurance underwriter. November 2011 Page 5

Procedures and Risks Pertaining To Short Term Altitude Acclimation An appraisal of the guidelines for healthy subjects undertaking limited exposure (days to weeks) to simulated altitude generated by normobaric hypoxia is provided here. This statement includes the risks and precautions associated with limited altitude exposure and procedures for the screening and management of subjects in an altitude environment. General: 1. Assessors: The assessment was made by Professor Phil Jakeman (UL) and Dr. Roger McMorrow. Roger McMorrow (MB, BCh, BAO, Dip Mtn Med, FCARCSI) is Consultant Anaesthetist at St. Vincent's University Hospital, Dublin and UIAA MedCom recognised expert in altitude medicine in July 2011. Dr McMorrow was a member of the medical and scientific research team on the Caudwell Xtreme Everest expedition to summit Everest in 2007. 2. Professional Governance: The Medical Commission of the Union Internationale des Associations d Alpinisme (UIAA http://www.theuiaa.org/medical_advice.html ) is the world umbrella organization for health and safety at altitude. UIAA MedCom provides guidelines to the risks and precautions associated with Limited Exposure (for some days or weeks) to normobaric hypoxia. These guidelines form the basis of the Risk Assessment and Operating Procedures governing simulated altitude exposure conducted within the Altitude Centre @ UL. 3. Simulated Altitude: UIAA differentiates the isobaric atmospheric oxygen (normobaric hypoxia) equivalent of low altitude to be 20.9 17.0% (corresponding to 0 1700 m), moderate altitude 16.9 13% (corresponding to 1700 3800 m and high altitude 12.9 10.7% (corresponding to 3800 5300 m). 4. Simulated Altitude is advantageous compared to normal altitude as it does not expose the subject to a change (decrease) in atmospheric pressure (hypobaria). Procedure for Residential Simulated Altitude Acclimation (SAA): To benefit from short term exposure to simulated altitude current US Olympic Committee guidelines recommend an exposure of 12-16h per day for a period of 2-4 weeks at a simulated altitude of between 2100 and 2500m. Within a normal 24h day, this is readily achieved by residing in a conditioned environment at rest and at sleep. The procedure for Simulated Altitude Acclimation (SAA) is a staged process that progressively increases either the degree of hypoxia (i.e. altitude) and/or the duration of exposure to hypoxia. The procedures adopted in this risk assessment follows current best practice (Chapman 2011, USOC International Altitude Training Symposium) as follows: i. Subjects are pre-screened for suitability by the NGB Medical Officer or GP using the PRESAA questionnaire (attached) and provided with a Personal Altitude Passport (PAP attached) in which the time spent in simulated altitude exposure is recorded. The passport also contains details of any potential reaction to altitude exposure, known as Acute Mountain Sickness (AMS), which is recorded and logged (see note 1) November 2011 Page 6

ii. Daily assessment of symptoms of AMS by SARRS questionnaire, resting SaO 2, heart and breathing rate will be undertaken. Should the subject or the Altitude Centre Staff note any undue signs of distress or adverse reaction as indicated by the SARR reports then the subject will be removed to a lower altitude. iii. subjects will reside within the altitude house for a period of up to 4 weeks; iv. the altitude house will be 'conditioned' to maintain the required altitude from 6pm to 8am; v. bedroom altitude will be set at 1700m for day 1-3 rising 300m to 2000m for days 4-14 to 2300m for day 15-21 and to 2600m for days 22-28 (see note 2) vi. The following measurements may be obtained prior to and/or during the period of SAA. a. A blood sample for haematological analysis (Approved Procedure SS023, SS024); b. A measurement of cardiopulmonary function (Approved Procedures SS033, SS037, SS062); c. A urine sample for the measurement of hydration status. Notes: 1. Acute mountain sickness (AMS) if the unacclimatized person sleeps at this altitude. Beside AMS there is normally no risk to any person who does not have severe cardiopulmonary illness or severe anaemia. The SARRS questionnaire is based on the Lake Louise Score for the monitoring of Acute Mountain Sickness (Roach RC, Bartsch P, Oelz O, et al.; Lake Louise Consensus Committee. The Lake Louise acute mountain sickness scoring system. In: Sutton JR, Houston CS, Coates G, eds. Hypoxia and molecular medicine. Burlington, VT: Charles S. Houston, 1993:272-274.) According to the Lake Louise scoring system, a score of 3 or more in the presence of a headache fulfils the diagnosis of AMS. 2. As per the IUAA guidelines, an increase in degree of hypoxic exposure (Altitude) is permissible following the recommended 3-day period of Acclimation Source: http://www.theuiaa.org/medical_advice.html November 2011 Page 7

National Altitude Training Centre Personal Altitude Passport Name: Andrew Niall Other November 2011 Page 8

Surname PRINT CAPITAL LETTERS Forename PRINT CAPITAL LETTERS D.O.B Sex Address d d /m m /y y y y male / female PRINT CAPITAL LETTERS PRINT CAPITAL LETTERS PRINT CAPITAL LETTERS Email person@xx.zzz Phone +353(0) 00 0000 Issue Date d d /m m /y y y y Please attach a recent passport photograph HERE Sports Profile Major Sport Event/Position Coach Best Performance #1 Best Performance #2 Best Performance #3 Best Performance #4 Swimming 800m Freestyle A. N. Other 2:14; Montreal Commonwealth Games, Silver Medal 2:14; Montreal Commonwealth Games, Silver Medal 2:14; Montreal Commonwealth Games, Silver Medal 2:14; Montreal Commonwealth Games, Silver Medal Anthropometry Haematology Height (m) 1.89 Hb (g/dl) 15.2 Body Mass (kg) 81.4 Hct (%) 42 BMI (kg/m 2 ) 22.1 MCHC 30.1 % Body Fat 18.9 EPO 3.7 FTMI (kg/m 2 ) 9.76 HIF 189 ALTMI (kg/m 2 ) 8.45 November 2011 Page 9

Simulated Altitude Training Record Start Date End Date Start Altitude (m) End Altitude (m) d d /m m /y y y y d d /m m /y y y y 2000 2500 Objectives/ Training Phase Comments Mid-Load Cycle Acclimation Phase a. Increase haemoglobin b. Increase Hct. No AMS Slight sleep disturbance on day 5 Signature Start Date End Date Start Altitude (m) End Altitude (m) d d /m m /y y y y d d /m m /y y y y 2000 2500 Objectives/ Training Phase Comments Mid-Load Cycle Acclimation Phase a. Increase haemoglobin b. Increase Hct. No AMS Slight sleep disturbance on day 5 Signature Start Date End Date Start Altitude (m) End Altitude (m) d d /m m /y y y y d d /m m /y y y y 2000 2500 Objectives/ Training Phase Comments Mid-Load Cycle Acclimation Phase a. Increase haemoglobin b. Increase Hct. No AMS Slight sleep disturbance on day 5 Signature Start Date End Date Start Altitude (m) End Altitude (m) d d /m m /y y y y d d /m m /y y y y 2000 2500 Objectives/ Training Phase Comments Mid-Load Cycle Acclimation Phase a. Increase haemoglobin b. Increase Hct. No AMS Slight sleep disturbance on day 5 Signature November 2011 Page 10

Simulated Altitude Acclimation Screening Questionnaire (PRESAA) This PRESAA Questionnaire is to be completed in consultation with the NGB Medical Officer or your General Practitioner. A confirmatory Medical Screening Form is provided below which must be signed and stamped by the Medical Officer or GP. Please provide a copy of the Information Sheet with you to inform the clinician of the nature of the study. NO YES Q1. Have you ever had medical problems at Altitude? (e.g. when holidaying in mountainous regions, trekking or skiing) If you have answered YES to Q1 please provide details below Q2. Have you ever suffered from or have you had any of the following: NO YES Cardiac Surgery Heart Attack Blood clot in the leg or lungs Coronary Angiography or Cardiac Stenting A Pacemaker Any cardiac disease or defect Heart Failure Chest surgery A stroke Epilepsy Blackouts Migraine or Headache Pulmonary Odema (fluid on the lungs) Cerebral Odema (fluid on the or swelling of the brain) Bronchitis November 2011 Page 11

Pneumonia Asthma Sleep Apnoea Anemia Sickle cell disease A blood transfusion Radiotherapy to the head, neck or chest If you have answered YES to any part of Q2 please provide details below Q3. Do you currently have or have you had in the past week any of the following: NO YES A chest infection Diarrhoea Vomiting Fever If you have answered YES to any part of Q3 please provide details below. November 2011 Page 12

Q4. Do you suffer from shortness of breath or chest pain when engaging in physical activity? NO YES If you have answered YES to Q4 please provide details below. Q5. Do you know of any other reason why you should NOT engage in altitude training? NO YES If you have answered YES to Q5 please provide details below. Q6. Any further comments of relevance to this person? November 2011 Page 13

Simulated Altitude Acclimation Screening Questionnaire (PRESAA) Declaration: I. declare that I have answered the PRESAT Please PRINT NAME questionnaire truthfully and to the best of my knowledge. Signed Date DD / MM / YYYY IMPORTANT: Should your health change over the course of engagement with the National Altitude Training Centre please inform the supervisory staff. November 2011 Page 14

Dear Clinician, This person has applied to undertake residential simulated altitude training at the National Altitude Training Centre of the University of Limerick. Details of the procedures to be undertaken are provided in the accompanying Information Sheet supplied to you by the subject. It is a requirement that any person undertaking altitude training is pre-screened by their clinician. The attached questionnaire has been constructed to inform this examination. Should you require any further information regarding simulated altitude training please do not hesitate to contact me. Sincerely Philip Jakeman Professor Phone: 061 20 2800 Email: phil.jakeman@ul.ie Confirmation of Medical Screening I examined. on / / and find no reason why PLEASE PRINT FULL NAME DD/ MM/ YYYY s/he could not successfully engage in simulated altitude training as described... Dated :../../. Signature Please insert practice stamp here. November 2011 Page 15

Simulated Altitude Response Record Sheet (SARRS) DATE / / 2011 TIME : Please answer the following questions truthfully and to the best of your knowledge and report any change in response to the staff at the Altitude Centre @ UL. When at simulated altitude did you experience any of the following? 1. A headache? NO YES Rating /3 If YES, please indicate the severity below: Headache No headache 0 Mild headache 1 Moderate headache 2 Severe headache, incapacitating 3 How long did the headache last? Did you take any medication (e.g. paracetamol)? If so, did the medication relieve the headache? 2. Nausea? NO YES Rating /3 If YES, please indicate the severity below: Nausea None 0 Poor appetite or nausea 1 Moderate nausea and/or vomiting 2 Severe nausea and/or vomiting 3 How long did the nausea last? Did you take any medication? If so, did the medication relieve the nausea? NO YES November 2011 Page 16

3. Fatigue? NO YES Rating /3 If YES, please indicate the severity below: Fatigue or weakness Not tired or weak 0 Mild fatigue or weakness 1 Moderate fatigue or weakness 2 Severe fatigue or weakness 3 How long did the fatigue last? Did you take any medication? If so, did the medication relieve the fatigue or weakness? NO YES 4. Dizziness? NO YES Rating /3 If YES, please indicate the severity below: Dizziness Not dizzy 0 Mild dizziness 1 Moderate dizziness 2 Severe dizziness, incapacitating 3 How long did the dizzines last? Did you take any medication? If so, did the medication relieve the dizziness? NO YES 5. Sleeping? NO YES Rating /3 If YES, please indicate the severity below: Difficulty sleeping Slept as well as usual 0 Did not sleep as well as usual 1 Woke many times, poor sleep 2 Could not sleep at all 3 How long did the sleep disturbance last? November 2011 Page 17

Did you take any medication? If so, did the medication relieve the nausea? NO YES Physiological measures: Oxygen saturation @ rest (sitting) (%) Heart Rate @ rest (sitting) Breathing Rate @ rest (sitting Urinary specific gravity (bpm) (breaths/min) g/ml Comments: Signed: SARRS total score of 3 to 5 = Mild AMS > 6 = Severe AMS A diagnosis of AMS is based on: 1. A rise in altitude in the last 4 days 2. Presence of a headache PLUS 3. Presence of at least one other symptom 4. A total score > 3 Decision rules: DO NOT ascend with symptoms of AMS i.e. score > 3 DESCEND if symptoms, i.e. AMS score, not improving or getting worse November 2011 Page 18